Carotid Artery DiseasesNCT03306771
The Relationship Between Morbid Obesity and Carotid Artery Stenosis
An observational study of Carotid Artery Diseases and Morbid Obesity, run by HaEmek Medical Center, Israel.
Trial summary
The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Morbid Obesity, Metabolic Syndrome
- What is being tested?
- Ultrasound Duplex
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates for first bariatric surgery
Who may be able to join
- Candidates for first bariatric surgery
Who cannot join
- Smokers or past smokers
- Patients who are post carotid artery intervention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study
The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.
Read the detailed description
The investigators hypothesis is that there is a direct relationship between morbid obesity and carotid artery stenosis. The investigators hypothesize that metabolic/Bariatric surgery improves the stenosis in the carotid artery.
This is a prospective comparative study on the candidates for metabolic/Bariatric surgery in the bariatric center, Emek Medical Center, Afula, Israel. The investigators will compare the candidate for metabolic surgery with metabolic syndrome risk factors to the ones without metabolic syndrome risk factors.
The assessment of the carotid artery will be done by Ultrasound Doppler before surgery and 6, 12 and 24 month post surgery.
- Conditions
- Carotid Artery Diseases, Morbid Obesity, Metabolic Syndrome
- Being tested
- Ultrasound Duplex
- Keywords
- Morbid Obesity, Carotid Stenosis, Metabolic Syndrome
- Medical subject headings
- Carotid Artery Diseases, Obesity, Morbid, Metabolic Syndrome, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound DuplexDiagnostic test
The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery
| Study group | Role | What they receive |
|---|---|---|
| Metabolic syndrome risk factors | Candidates for bariatric surgery who have metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity Receives: Diagnostic Test: Ultrasound Duplex | |
| No metabolic Syndrome risk factors | Candidates for bariatric surgery who lack metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity Receives: Diagnostic Test: Ultrasound Duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between morbid obesity and carotid artery stenosis
Evaluate the correlation between the two in order to identify high risk patient for carotid stenosis without metabolic syndrome risk factors
Measured: 24 months post surgery
Secondary outcomes (2)
Changes in Intimal -media thickness
To compare the baseline Intimal-media thickness before surgery to the one post-surgery by the use of Ultrasound
Measured: Before bariatric surgery, and 6,12,24 months after the surgery
Changes in the carotid artery velocity
To compare the baseline carotid artery velocity before surgery to the one post-surgery by the use of Ultrasound Doppler
Measured: Before bariatric surgery, and 6,12,24 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startJun 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uri Kaplan , MD, HaEmek Medical Center, Israel
- Investigators
- Uri Kaplan, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306771
- Sponsor's protocol ID
- 0126-17-EMC
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ribeiro Filho FF, Mariosa LS, Ferreira SR, Zanella MT. [Visceral fat and metabolic syndrome: more than a simple association]. Arq Bras Endocrinol Metabol. 2006 Apr;50(2):230-8. doi: 10.1590/s0004-27302006000200009. Epub 2006 May 23. Portuguese.
PubMed 16767289Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. doi: 10.1053/meta.2001.27213.
PubMed 11735101Sharma AM. Obesity and cardiovascular risk. Growth Horm IGF Res. 2003 Aug;13 Suppl A:S10-7. doi: 10.1016/s1096-6374(03)00047-9.
PubMed 12914719Pignoli P, Tremoli E, Poli A, Oreste P, Paoletti R. Intimal plus medial thickness of the arterial wall: a direct measurement with ultrasound imaging. Circulation. 1986 Dec;74(6):1399-406. doi: 10.1161/01.cir.74.6.1399.
PubMed 3536154Marchesi F, Giacosa R, Reggiani V, De Sario G, Tartamella F, Melani E, Mita MT, Cinieri FG, Cecchini S, Ricco' M, Salcuni P, Roncoroni L. Morphological Changes in the Carotid Artery Intima after Gastric Bypass for Morbid Obesity. Obes Surg. 2017 Feb;27(2):357-363. doi: 10.1007/s11695-016-2279-9.
PubMed 27389676Sarmento PL, Plavnik FL, Zanella MT, Pinto PE, Miranda RB, Ajzen SA. Association of carotid intima-media thickness and cardiovascular risk factors in women pre- and post-bariatric surgery. Obes Surg. 2009 Mar;19(3):339-44. doi: 10.1007/s11695-008-9783-5. Epub 2008 Dec 13.
PubMed 19083071
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Morbid Obesity and Carotid Artery Stenosis - a Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT03306771
- Acronym / sponsor ID
- 0126-17-EMC
- Conditions
- Carotid Artery Diseases, Morbid Obesity, Metabolic Syndrome
- Keywords
- Morbid Obesity, Carotid Stenosis, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.
Detailed description
The investigators hypothesis is that there is a direct relationship between morbid obesity and carotid artery stenosis. The investigators hypothesize that metabolic/Bariatric surgery improves the stenosis in the carotid artery.
This is a prospective comparative study on the candidates for metabolic/Bariatric surgery in the bariatric center, Emek Medical Center, Afula, Israel. The investigators will compare the candidate for metabolic surgery with metabolic syndrome risk factors to the ones without metabolic syndrome risk factors.
The assessment of the carotid artery will be done by Ultrasound Doppler before surgery and 6, 12 and 24 month post surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome risk factors | – | Diagnostic Test: Ultrasound DuplexCandidates for bariatric surgery who have metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity |
| No metabolic Syndrome risk factors | – | Diagnostic Test: Ultrasound DuplexCandidates for bariatric surgery who lack metabolic syndrome risk factors will be evaluated by Ultrasound duplex before the bariatric surgery and 6,12 and 24 months post surgery for Intimal-Media Thickness and Carotid artery velocity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates for first bariatric surgery
Key inclusion criteria (1 listed)
- Candidates for first bariatric surgery
Key exclusion criteria (2 listed)
- Smokers or past smokers
- Patients who are post carotid artery intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound DuplexThe two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery | Diagnostic test | Metabolic syndrome risk factors, No metabolic Syndrome risk factors |
Primary outcome
Correlation between morbid obesity and carotid artery stenosis
Time frame: 24 months post surgery
Evaluate the correlation between the two in order to identify high risk patient for carotid stenosis without metabolic syndrome risk factors
2 secondary outcomes
Changes in Intimal -media thickness
Time frame: Before bariatric surgery, and 6,12,24 months after the surgery
Changes in the carotid artery velocity
Time frame: Before bariatric surgery, and 6,12,24 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Background: PubMed 16767289Ribeiro Filho FF, Mariosa LS, Ferreira SR, Zanella MT. [Visceral fat and metabolic syndrome: more than a simple association]. Arq Bras Endocrinol Metabol. 2006 Apr;50(2):230-8. doi: 10.1590/s0004-27302006000200009. Epub 2006 May 23. Portuguese.
- Background: PubMed 11735101Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. 2001 Dec;50(12):1499-504. doi: 10.1053/meta.2001.27213.
- Background: PubMed 12914719Sharma AM. Obesity and cardiovascular risk. Growth Horm IGF Res. 2003 Aug;13 Suppl A:S10-7. doi: 10.1016/s1096-6374(03)00047-9.
- Background: PubMed 3536154Pignoli P, Tremoli E, Poli A, Oreste P, Paoletti R. Intimal plus medial thickness of the arterial wall: a direct measurement with ultrasound imaging. Circulation. 1986 Dec;74(6):1399-406. doi: 10.1161/01.cir.74.6.1399.
- Background: PubMed 27389676Marchesi F, Giacosa R, Reggiani V, De Sario G, Tartamella F, Melani E, Mita MT, Cinieri FG, Cecchini S, Ricco' M, Salcuni P, Roncoroni L. Morphological Changes in the Carotid Artery Intima after Gastric Bypass for Morbid Obesity. Obes Surg. 2017 Feb;27(2):357-363. doi: 10.1007/s11695-016-2279-9.
- Background: PubMed 19083071Sarmento PL, Plavnik FL, Zanella MT, Pinto PE, Miranda RB, Ajzen SA. Association of carotid intima-media thickness and cardiovascular risk factors in women pre- and post-bariatric surgery. Obes Surg. 2009 Mar;19(3):339-44. doi: 10.1007/s11695-008-9783-5. Epub 2008 Dec 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri Kaplan, MD principal investigator
haemek medical center
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Morbid Obesity, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Kaplan, MD (972-50-5315311, kaplanuri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between morbid obesity and carotid artery stenosis (time frame: 24 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306771, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.